Clinical Research Coordinator

9 hours ago


Waterloo, Ontario, Canada ICON Strategic Solutions Full time
Job Title: Study Support Assistant

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Key Responsibilities:
  • Recognize, exemplify, and adhere to ICON's values, which center around our commitment to People, Clients, and Performance.
  • Embrace and contribute to our culture of process improvement, focusing on streamlining processes, adding value to our business, and meeting client needs.
  • Provide general administrative support to the team.
  • Support the Study Start-Up Leads, including tracking, filing, and other coordinating tasks.
  • Assist the team with submission documentation and guidelines, as appropriate.
  • Collate and verify submission documentation for completeness before submission to the Regulatory/Competent Authority (CA)/Ethics Committee (EC) and other relevant authorities.
  • Coordinate, dispatch, and track submissions to CNEC and other relevant authorities.
  • Assist in the translation of documents required for submission to CNEC and other relevant authorities.
  • Coordinate the translation of documents required for submission to CNEC and other relevant authorities.
  • Assist the team with submission progress tracking by updating the relevant ICON/Sponsor tracking system, as required.
  • Copy and route incoming correspondence, internal documentation, etc., as appropriate.
  • Be familiar with ICH GCP and relevant ICON SOPs.
  • Be competent with ICON/Sponsor Clinical Trial Management System (CTMS), as appropriate.
  • Set up, organize, and maintain department electronic filing systems.
  • Assist in coordinating payments to CA/EC and other relevant authorities, as appropriate.
  • Set up and organize meetings, as requested.
  • Attend team meetings and generate meeting minutes.
Requirements:
  • University degree in Health Science or a related field (an equivalent combination of education, training, and work experience may be considered).
  • Two years of experience in Clinical Research or a related industry.
  • Oncology experience required.
  • Understanding of Good Clinical Practices/International Committee on Harmonization principles.
  • Strong social and interpersonal skills (written and oral).
  • Confident speaking to Health Care Professionals.
  • Ability to influence without authority.
  • Work effectively both independently and in a team environment.
  • Self-motivated and able to display autonomy and initiative.
  • Apply a strong attention to detail.
  • Seek multiple demands/projects simultaneously.
  • Effective time management skills.
  • Passion lies in customer service.
  • Good knowledge of MS Office (Word, Excel, PowerPoint) and using multiple computer systems.


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